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ProPharma · 3 days ago

Clinical Research Associate (West Coast)

Raleigh, NC

Full-time

Onsite

Mid, Senior Level

4+ years exp

ProPharma has been enhancing patient health and wellness for 20 years by providing consulting solutions to biotech, med device, and pharmaceutical organizations. The Clinical Research Associate will manage and execute clinical study plans, ensuring compliance and effective communication between sponsors and clinical sites.

BiopharmaMedicalPharmaceutical

No H1B

Responsibilities

Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies

Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships

Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates

Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables

Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams

Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements

Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies

Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team

Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate

Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management

Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members

Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study

Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members

Communicate project specific information to/from trial sites through teleconferences, newsletters, etc

Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis

Document monitoring activities in monitoring visit reports and follow-up letters

Communicate serious issues to appropriate parties, in a timely manner

Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed

Participate in Investigator Meetings, and other study trainings and meetings as required

Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Support and comply with the company’s Quality Management System policies and procedures

Maintain regular and reliable attendance

Ability to act with an inclusion mindset and model these behaviors for the organization

Ability to work designated schedule

Ability to work nights and/or weekends, as needed

Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day

Ability to work on a computer and phone simultaneously

Ability to use a telephone through a headset

Ability to travel 50% of working time away from work location may include overnight/weekend travel

Qualification

Clinical research monitoringRegulatory complianceData managementElectronic Data Capture (EDC)Informed consent proceduresAdverse event reportingGCP guidelinesCertifications in clinical researchETMF systemsFluent in Spanish

Required

Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience or Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience

4+ years clinical research monitoring experience or equivalent experience

No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability

Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems

Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively

Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices

Meticulousness with a focus on accuracy and precision in all tasks and activities

Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy

Demonstrated ability to perform the essential duties of the position with or without accommodation

Authorization to work in the United States without sponsorship

This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish